Kornimate/medical-research-clean huggingface dataset:
validation of biomarkers performance to reduce antibiotics overuse in newborns with suspected clinical signs of infections

Conditions: Neonatal Late Onset Sepsis

Summary: late-onset neonatal sepsis (los), occurring in newborn of at least 7 days of life, is frequently observed in neonatal intensive care units (nicus) and potentially severe (mortality, neurologic and respiratory impairments). despite its high prevalence, a reliable diagnostic remains difficult. currently, nonspecific clinical signs that might be related to other neonatal conditions such as prematurity and birth defects, are used to determine the diagnosis of los. laboratory results of biological markers, such as c-reactive protein (crp) and procalcitonin (pct) are often delayed in comparison with los onset. blood culture results are too late and lack sensitivity. this explains why excessive antibiotic use is observed in a large proportion of nicu hospitalized newborns. this results in an increased antibiotic resistance, microbiota modification, neonatal complications (pulmonary, ophthalmologic and neurologic) and mortality. a previous study (emeraude) aimed to identify new biomarkers to early exclude the diagnosis of los, in order to limit antibiotic overuse. this study including 230 neonates revealed high performances of il6, il10, ngal and combinations of pct/il10 and ptx3/ngal. the main objective of the present study will be to validate the performances of these biomarkers in another cohort. the secondary objectives will be to explore transcriptomic biomarkers and salivary biomarkers.


Eligibility criteria:
inclusion criteria: * patient hospitalized in the nicu of one of the two recruiting centers at the time of inclusion * patients aged ≥ 7 days * patients weighted ≥ 500 g the day of blood sample * patients with suggestive signs of los including at least one of the following:fever \> 38°c; tachycardia \> 160bpm; capillary refill time \> 3 seconds; grey and/or pale skin complexion; apnea/ bradycardia syndrome, bloating; vomiting; rectal bleeding; hypotonia; lethargy; seizures without other obvious cause; increased ventilatory support and/or increased fio2; cutaneous rash; inflammation at the needle-puncture site of the central venous catheter; or any other condition for which the clinician suspected an infection * patients with a standard of care blood sampling, including at least a blood culture; exclusion criteria: * patient treated with antibiotics for a bacteriologically confirmed infection at the time of sampling or within 48 hours prior to sampling * patient who underwent surgery within the previous 7 days * patients vaccinated within the previous 7 days * patient who received treatment with systemic corticosteroid therapy in the 48 hours prior to sampling * patient with severe combined immunodeficiency * opposition from parent(s)/guardian(s)

Keywords: neonatal sepsis, biomarker diagnostic, antibiotic use preterm neonates nicu
covid-19 sequelae: treatment and monitoring. a dietary supplement based on sea urchin eggs with echinochroma a

Conditions: Long COVID

Summary: the aim of this study is to assess the efficacy and efficiency of a nutraceutical from sea urchin eggs with echinochrome a in the inflammation of tissues in subjects with long corona virus (covid) syndome

this is a double-blind placebo-controlled study in approximately 60 subjects with long covid syndrome. after being informed about the study and potential risks, all subjects giving written informed consent will be screened to assess initial respiratory, cardiological inflammatory, neurological and emotional conditions. prior to the first administration of the treatment, subjetcs will be randomized to receive three vials of the dietary supplement with sea urchin eggs extract with presence of the antioxidant echinochrome a or placebo. according with the acro suggestions this study is focus on the patients. subjects will be monitor by a telemedicine platform called skymed developed for this study to assess their health daily and will have a weekly virtual meeting with a counselors to assess emotional state. subjects will attend tp the hospital, at the beggining of the study, and after finishing the vials of the dietary supplement (30, 60 and 90 days). clinical, cardiological, neumonological and neurological studies will carried out to asses the systemic health as well as the quality of life indicators. inflammation, trombolotic and inmune indicators will be assess in blood samples (basal, 30, 60 and 90 days). the main objetivec behind this clinical trial is to diminish ros in the cells, enhance gluthation pathways and diminish cellular inflammation. echinochrome a is a powerfull marine poliphenol with known antioxidant activity found in the eggs, shells and spines of sea urchins, that had been use in eastern medicien for a long time. powder of sea urchin eggs are mention in materia medica back far 1647 as a powerfull anti inflamation agent.

Eligibility criteria:
inclusion criteria: 1. positive diagnosis of covid-19 in at least the last 12 weeks 2. diagnosis of covid persistent, covid sequalea, long covid 3. adult men or non-pregnant adult women between the ages of 18 and 60. 4. the patient (or legally authorized representative) provides your informed consent before initiating any study procedure. 5. the patient (or legally authorized representative) understands and agrees comply with the planned study procedures. 6. agreement not to participate in another trial ofintervention for the treatment of covid-19 until day 60 after the start of the trial. exclusion criteria: * 1. patients without persistent covid symptoms. 2. patients unable to give informed consent. 3. patients without a positive result for covid-19. 4. pregnancy or lactation. 5. in the doctor's opinion, the patient with advanced organ dysfunction that would not make participation appropriate.

Keywords: covid-19 sequalae long covid lung telemedicine brain biomarker
short contact protocols to reduce pain during 10% ala gel red-light photodynamic therapy of actinic keratoses

Conditions: Actinic Keratosis

Summary: the goal of this clinical trial is to see if shorter photodynamic therapy (pdt) treatment times will still be effective at treating actinic keratoses (ak) while reducing or eliminating the pain that patients sometimes experience during conventional pdt treatment. the main questions it aims to answer are: * will the application of the nanoemulsion (10% ala gel), in the absence of occlusion, still achieve significant inflammation and lesion clearance? * will shortened incubation times of ameluz still achieve significant inflammation and lesion clearance? * will the new test regimens achieve reduced pain during illumination? * will the new test regimens be safe? participants will be randomly assigned to one of three treatment regimens, which will determine the length of time that the topical medication will incubate on the face before red light exposure in pdt treatments. the incubation period will be either 10 minutes, 20 minutes, or 60 minutes.


Eligibility criteria:
inclusion criteria: * minimum of 10 actinic keratoses lesions on the face. * female subjects must not become pregnant during the study * subjects must be able to understand and willing to sign a written informed consent document. exclusion criteria: * pregnant or nursing. * using any topical treatment on their aks; must stop at least one month prior. * currently undergoing treatment for other cancers with medical or radiation therapy. * patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material. * patients with history of a photosensitivity disease, such as porphyria cutanea tarda.

Keywords: actinic keratoses actinic keratosis photodynamic therapy
can individuals control pressure in their esophagus.

Conditions: Gastroesophageal Reflux

Summary: to establish to what degree individuals can increase esophageal high pressure zone (hpz) after instruction in deep breathing as evidenced by concurrent manometric pressure readings.

pressure in the lower esophagus has been negatively associated with reflux symptoms: the lower the pressure, the more reflux symptoms. this pressure can be augmented with deep abdominal breathing. this can be detected during esophageal manometry, when a pressure catheter is placed into the esophagus. manometry is routinely done for swallowing disorders. this study will take place just after a routine manometry test, when the subject still has the catheter in place. all that is required for the research portion is to observe manometry readings while they breathe, then when they deep breath, then breathe after they have been cued or coached to deep abdominal breathing. this is done in sequence to establish how quickly this pressure can be improved. this coached breathing is then prescribed as a routine exercise and long term follow up performed via phone to see how their reflux symptoms have responded.

Eligibility criteria:
inclusion criteria: -eligibility is forwarded to all individuals undergoing routine esophageal manometry. they would have had to have met all eligibility criteria for this procedure. exclusion criteria: -individuals undergoing modified barium swallow studies (mbss). exclusion from mbss would preclude inclusion in this study.
human perception of odors and odor blockers

Conditions: Tobacco Smoking; Smoking Behaviors

Summary: the goal of this clinical trial is to determine whether blockers of perception of key odorants in cigarette smoke have any utility in smoking cessation. the main question it aims to answer is: • can odor blockers be used to suppress perception of the intensity of cigarette smoke in ways that reduce the ability of the odor of cigarette smoke to increase the urge to smoke. participants will be asked to smell up to 20 odor samples per session and report on odor pleasantness and desire to smoke.

the experimental treatments include controls (clean air, irrelevant odor), blocking odors, cigarette smoke odor, and cigarette smoke odor mixed with blocking odors or irrelevant odor. to obtain cigarette smoke odor a 1 inch length of a 1r6f research cigarette is burned to completion in a sealed 5 gallon chamber fitted with septa. using a syringe fit with a needle and filter, 60 ml aliquots of smoke odor are obtained. these smoke odor aliquots, along with blocking odors, are injected into odor sample bags fit with a septum and a valve that can be attached to the cpap nose mask worn by each participating smoker. participants open the valve, inhale once through the nose, close the valve, and then remove the bag from the mask before reporting odor pleasantness and the desire to smoke. a 2 - 3 min wait period is enforced between each odor presentation to prevent odor adaptation and to allow acute motivational effects to subside. in a testing session a participant sniffs 4 concentrations of a mixture of 2 blocking odors, along with control odor samples. presentation order is randomized. each participant is assigned their own cpap nose mask, and masks are disinfected after use. participants also provide demographic (age, sex, ethnic and racial background) and smoking history information (cigarettes per day, preferred brand, age at onset, and time since last cigarette).

Eligibility criteria:
inclusion criteria: * smoker exclusion criteria: * non smoker * self reported inability to smell or taste

Keywords: odors sensory perception nicotine addiction motivation
prevalence of facial asymmetry among orthodontic patients

Conditions: Facial Asymmetry

Summary: to estimate the prevalence of facial asymmetry

the objectives of the present study are: * to estimate the prevalence of facial asymmetry among egyptian population, according to type, sex, and age. * to provide an insight into the key aspects to be taken into consideration while accomplishing an accurate diagnosis and formulation of rational integrated orthodontic-surgical treatment plan that considers correction of all aspects of the asymmetry.

Eligibility criteria:
inclusion criteria: * between 18-40 years old of both sexes who asked for orthodontic treatment exclusion criteria: * • no previous orthodontic treatment. * photographs of poor quality. * any hereditary diseases or syndromes such as down's syndrome or cleidocranial dysostosis. * any disease of the jaw that might have affected the normal growth of permanent dentition.
the effects of post-hospitalization telehealth care in the patients who admitted via emergency department

Conditions: General Medical Disease

Summary: the investigators will perform and evaluate a post-hospitalization telecare system for compensating the discontinuity from the hospitalist care system.

at present, taiwan's population has become an aging society since recent decade. those older than 65 years had achieved 10.4% in 2008. meanwhile, the proportion of hosts with underlying comorbid illness or immunocomprised status is increasing worldwide. in the trend of aging population, telehealth care will be important to extend the care system in post-hospitalization home care. in the past, thelehealth care has shown a good executive performance in the patients with congestive heart failure and post-operation follow-up. however, in dealing the patients with acute illness needing hospitalization, the telehealth system has not implemented yet. in regard to national health insurance (nhi) of taiwan, hospitalization costs a lot in overall budget. reduction of re-hospitalization in those with/without co-morbidity is a important issue for taiwan nhi. therefore, we plan to conduct the telehealth care system in post-hospitalization course in those admitted from emergency department. we observe the re-hospitalization rate and analyze the risk factors. in addition, we hypothesize the telehealth care will decrease the rate of re-hospitalization.

Eligibility criteria:
inclusion criteria: * older than 18 years * discharged alive from our hospitalist-care ward to home care * match diagnosis of general medicine exclusion criteria: * younger than 18 years * discharged to care facility other than home * died in hospital * communication deficits * no telephone at home * patient or family refused
cost-effectiveness of extracorporeal life support treatment

Conditions: Critically Ill

Summary: this study evaluates patients on ecls treatment as considered appropriate with mortality and health related quality of life and costs.

a direct comparison between usual care and ecls treatment is difficult. alternatively we compare predicted mortality for every patient based on validated scoring systems at the initiation of ecls treatment with the actual outcome, so every patient is his own control. primary outcome is hrqol assessed with the eq-5d questionnaire at 1 year. healthcare costs and costs from a societal perspective are prospectively measured.

Eligibility criteria:
inclusion criteria: * admitted to intensive care * treated with extracorporeal life support exclusion criteria: * none

Keywords: extracorporeal life support health related quality of life
post-marketing surveillance of the cinepazide maleate injection: a real world study

Conditions: Adverse Drug Reaction; Cinepazide; Stroke

Summary: cinepazide maleate injection is widely used in cerebrovascular disease in china. the safety of the cinepazide, especially the blood system, has not been fully evaluated in chinese population. in order to improve the rational use of cinepazide, the investigators observe its clinical use in the real world in china, evaluate its safety and clinical benefit in a large chinese population.

cinepazide was firstly approved in france in 1974, and the formulations are injection and tablet. products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some european countries, such as france, spain, italy. in some aisa countries, it has not been re-registered in japan in 2000s, and the injection is still used in china and korea. in china, cinepazide maleate injection was approved by china food and drug administration(cfda) in 2002, and widely used in cerebrovascular disease. the safety of the cinepazide, especially the adverse drug reactions in the blood system, has not benn fully evaluated in chinese population. in this study, clinical pharmacists in selected hospitals will record the clinical use and the adverse drug reactions/ adverse drug events of this injection. this real world study for cinepazide maleate injection with 18000 patients will be conducted from sep. 2012 to june. 2014.

Eligibility criteria:
inclusion criteria: * inpatient using the cinepazide in the department of neurology exclusion criteria: * none

Keywords: cinepazide adverse drug reaction safety real world study
corneal epithelial and stromal thickness distribution in keratoconus

Conditions: Keratoconus; Astigmatism

Summary: the purpose of the study was to identify corneal epithelial- and stromal-thickness distribution patterns in keratoconic eyes using spectral-domain-optical coherence tomography (sd-oct). study hypothesis: sd-oct provides necessary details about the distribution of corneal epithelial and stromal thicknesses for identification of a pattern characteristic for early keratoconus.

purpose of the study: to characterize epithelial and stromal thickness distribution in keratoconic eyes and to develop epithelial and stromal thickness-based variables for keratoconus detection. methodology: sd-oct corneal scans of 20 eyes with keratoconus (group 1) and 20 healthy eyes with \> 2 diopters (d) of corneal astigmatism as controls (group 2) are studied. keratoconus patients referred to the eye dpt. of the university hospital north norway for cxl (corneal collagen cross-linking)- treatment and healthy subjects seeking preoperative evaluation for refractive surgery at synslaser® kirurgi as tromsø clinic are examined by corneal sd-oct as a part of their routine examination. analysis of their sd-oct corneal scans is used for the purpose of this study.two cross-sectional meridional corneal profiles (along steepest and flattest meridians, located by a scheimpflug-based corneal topography) for each individual are obtained by using a rtvue100® (optovue inc. fremont, california, usa), 26000-hz sd-oct across the central 6mm diameter of the cornea.

Eligibility criteria:
inclusion criteria: * keratoconus group: confirmed diagnosis of keratoconus * astigmatism group: healthy eyes with astigmatism of \>2.0 d exclusion criteria: * keratoconus group: keratoconus \> stage 3 on krumeich scale * astigmatism group: no signs of keratoconus

Keywords: keratoconus astigmatism cornea sd-oct
impact of critical limb ischemia on long term cardiac mortality in diabetic patients undergoing percutaneous coronary revascularization

Conditions: Critical Limb Ischemia

Summary: prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary intervention (pci) in whom development of critical limb ischemia was prospectively assessed by a dedicated diabetic foot clinic. cardiac mortality at 4-year follow-up was the primary endpoint of the study.


Eligibility criteria:
inclusion criteria: * diabetes mellitus * need for coronary revascularization * age \> 18 years exclusion criteria: * clinical contraindications to prolonged double antiplatelet therapy * life expectancy \< 1 year * lack of consent
a study to examine safety, pharmacokinetics, and pharmacodynamic of pf 06412562 in subjects with schizophrenia

Conditions: Schizophrenia

Summary: this study is designed to investigate the safety, tolerability pharmacokinetics and pharmacodynamic effects of pf-06412562 following multiple dose administration as mr tablets in subjects with schizophrenia.

b7441007 is a randomized, double-blind, placebo-controlled, sponsor open, parallel group design, phase 1b study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of 3 doses of pf-06412562 (3 mg bid, 9 mg bid and 45 mg bid) over 15 days in approximately 100 psychiatrically stable (as defined by the inclusion and exclusion criteria) subjects with schizophrenia are on background treatment with soc antipsychotics and other psychotropic medications. all doses will be administered twice daily, with approximately 12 hours between each dose.

Eligibility criteria:
inclusion criteria: 1. subjects with schizophrenia both male and female 2. evidence of stable schizophrenia symptomatology for at least 3 months (no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia, etc). 3. subjects must be in ongoing maintenance antipsychotic therapy other than clozapine (oral or depot) on a stable medication treatment regimen for for at least 2 months prior to day 1, including concomitant psychotropic medications. exclusion criteria: 1. history of seizure 2. pregnant or nursing females 3. evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening and at the time of dosing).
nitric oxide and the autonomic nervous system

Conditions: Hypertension; Pure Autonomic Failure

Summary: the amount of blood flowing to the different parts of the body is regulated by the autonomic (automatic) nerves and by local factors produced by the blood vessels. nitric oxide (no) is one of the most important of these metabolic factors. if the production of no is slowed or stopped the amount of blood to the different parts of the body is decreased. there is increasing knowledge that no mechanisms are impaired in a number of medical conditions. no function is reduced in patients with risk factors for atherosclerosis (hardening of the arteries) such as hypercholesterolemia (patients with high cholesterol), or diabetes mellitus, and is also impaired in smokers. this no "deficiency" is believed to contribute to the greater cardiovascular risk that marks these patient populations. this study is designed to examine if endothelial nitric oxide is an important control mechanism of blood pressure under normal conditions, and if impairment of nitric oxide contributes to hypertension.


Eligibility criteria:
inclusion criteria: * adult subjects. * 18 to 85 years. * non-smokers or long term smokers for specific aim 6. * drug-free. * long term hypertension in specific substudy 3, patients with autonomic failure in specific aims 4 and 5, diabetes mellitus in specific aim 5. exclusion criteria: * being on any medication other than antihypertensives (for hypertensives), autonomic medications (for autonomic failure \[af\] patients), insulin or other treatment for diabetes (for diabetic patients). * having pulmonary, renal, hematopoietic, hepatic and/or cardiac disease.

Keywords: endothelial nitric oxide l-nmma trimethaphan autonomic nervous system nitric oxide inhibition